The off-label prescribing of drugs has become a serious problem over the past decade. Doctors are adjusting dosage levels and prescribing drugs for medical indications and treatment durations for which the drugs were never approved or intended.
When the FDA approves a drug, it also approves the labeling for the drug, which explains the manner in which the medication is to be used. While physicians may prescribe approved drugs as they see fit, its against the law for drug companies to promote drugs for uses outside of the approved labeling but they do it all the time.
Neurontin remains the most notorious example of an illegal, but highly successful, off-label marketing campaign. The drug was approved for the limited use of treating epileptic seizures but nonetheless, became an overnight blockbuster with sales that soared from $97.5 million in 1995, to more than $2.5 billion in 2003.
While Neurontin might be the most notorious, it is certainly not the only problem. A study published in the May 8, 2006, Archives of Internal Medicine, determined that more than one out of every 7 prescriptions written for 160 commonly used drugs were for off-label uses that lacked scientific support.
The study was based on information from the IMS Health National Disease and Therapeutic Index that defines drug prescribing patterns and provides market data on drug companies.
In 2001, an estimated 150 million prescriptions, or 21% of prescriptions written, were for off-label use, according to the Archives study.
To reach its results, the study first determined whether a prescription was off-label and then assessed the level of available scientific evidence supporting the use, through the Drugdex system, a comprehensive summary of evidence supporting off-label uses of prescription drugs.
The study found that 73%, or 109 million off-label prescriptions, had little or no supporting evidence. The study does not explain why doctors prescribe so many drugs off-label but one explanation may be that "both physicians and patients have misunderstood the role of the FDA," the study's lead author Randall Stafford says.
"I think there's sort of a presumption that if a drug has made it onto the market," he notes, "the FDA has vouched for its safety and efficacy for all of its potential uses."
One way drug companies have been able to increase the off-label sale of drugs is by influencing doctors in public institutions, and state policy makers, who are involved in the development of drug formularies that list which drugs will be used in state institutions and by persons covered by government health care programs like Medicaid and Medicare.
Allen Jones, a former Pennsylvania fraud investigator, explains that each state has a menu of approved drugs that doctors must prescribe to persons in state institutions. "Before a drug can be prescribed by a state physician for somebody in the state system," he says, "it has to be on the list."
According to Mr Jones, the drug companies "have bought the decision-making process from our government officials all the way down to the guy who decides what drugs get on the formulary."
Doctors who sit on the expert panels and decide which drugs will be on the lists, he says, are paid by drug companies to give positive opinions in order to circumvent the FDA approval process.
"The FDA has no control over what an individual doctor does or says," Mr Jones explains, "the pharmaceutical industry has funded a mechanism whereby they can gather favorable opinions."
"They then amplify and magnify those opinions," he says, "and put them in the form of a treatment protocol that can be implemented in any state with the approval of a few key decision-makers."
Stacking the deck with industry friendly "experts" is apparently common. An investigation by the scientific journal Nature found "extensive" financial connections between drug companies and the advisory panels, with as many as 70% of the panels affected. In one instance, Nature found every member of a panel had received payments from the company making the drug that was recommended.
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